MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after a right tkr surgery in 2019, plaintiff continued to experience significant and excruciating pain in the right knee.Plaintiff was diagnosed with a metal allergy to cobalt, chromium, and nickel.Plaintiff underwent revision surgery on (b)(6) 2021 to replace the implants with ones that did not contain metals.(case-(b)(4)) during revision surgery, once the surgeon cemented the replacement implants it was known that the new implants also contained cobalt and chromium therefore the surgeon had to chisel away the cement and remove the new implants (case-(b)(4)) this second procedure resulted in bone fracture in the right leg, causing pain and severe post-surgical discomfort.Plaintiff has had to undergo additional rehabilitation treatment and suffers from permanent instability and restricted mobility.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

*us legal* it was reported that, after a right tkr surgery in 2019, plaintiff continued to experience significant and excruciating pain in the right knee.Plaintiff was diagnosed with a metal allergy to cobalt, chromium, and nickel.Plaintiff underwent revision surgery on (b)(6) 2021 to replace the implants with ones that did not contain metals.(b)(4) during revision surgery, once the surgeon cemented the replacement implants it was known that the new implants also contained cobalt and chromium therefore the surgeon had to chisel away the cement and remove the new implants (b)(4) this second procedure resulted in bone fracture in the right leg, causing pain and severe post-surgical discomfort.Plaintiff has had to undergo additional rehabilitation treatment and suffers from permanent instability and restricted mobility.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, approximately 2 years post-primary right tka the patient underwent revision due to continued ¿significant and excruciating pain¿ for several months following the 2019 tka and a new diagnosis of metal allergies to cobalt, chromium, and nickel.No supporting documentation has been provided as of the date of this medical investigation.Without the requested documentation/ information, the root cause of the reported events could not be further assessed and the patient impact beyond that which was reported can not be determined.No further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to material in use, patient reaction or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the reported diagnosed of metal allergies ¿ cobalt, chromium and nickel may have contributed to this patient¿s hypersensitivity symptoms, however, this diagnosis and reported reactions are not associated with a mal-performance of the implants.The fracture that resulted from the removal of the first revision implants could be contributed to human error in providing components with the same material make-up, and once again not a mal performance of the implants.No further clinical/medical assessment is warranted at the time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes that could contribute to the reported event have been identified as patient reaction, post-operative healing issue and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Event Description

Was reported that, after a right tkr surgery on (b)(6) 2020, plaintiff continued to experience severe, excruciating pain in the right knee.On (b)(6) 2020, plaintiff was diagnosed with a metal allergy to cobalt, chromium, and nickel.Plaintiff underwent revision surgery on (b)(6) 2021, to replace the implants with ones that did not contain metals.During revision surgery, after the surgeon had cemented the knee replacement implants, it was known that the tibial stem contained cobalt/chromium containing nickel.The implant was unimpacted.The cement was removed from the tibial canal and the tibial stem was removed off this component and a titanium stem 10x120mm was impacted.(b)(4) this second procedure resulted in a bone fracture in the right leg, causing severe post-surgical pain and discomfort.Plaintiff had to undergo additional rehabilitation treatment and has been treated conservatively, it is unknown if she has had additional revision surgery.(b)(4).

Manufacturer Narrative

Section b5 was updated due to new information received.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14192067
• MDR Text Key: 289951305
• Report Number: 1020279-2022-01933
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Sex: Female